MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10015

Device Problems Nonstandard Device (1420); Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Event Description

It was reported that the ri robotic drill attachment was stuck on the end of the handpiece.It was able to be removed with a handpiece diagnostic test.They tested the piece again and it was stuck again.There was no delay due to the issue since it was noticed after a cori-assisted surgery.The visual inspection found that the long attachment was out of specifications.The torque was found to be on 8 oz.In, instead of 20 oz.In as design (the nut on the back of the cori drill attachment that holds in the bearings and spacers seems to be loosening).

Manufacturer Narrative

The cori drill long attachment was returned for evaluation.  a relationship between the reported event and the device was established.  the reported event was visually and functionally confirmed. the long attachment was out of specifications.The torque was found to be on 8 oz.In, instead of 20 oz.In as design.Even when the reported issue was confirmed visually, a functional evaluation was performed.The long attachment got stuck in the drill.Once the torque was adjust, it operated as design.A supplemental mdr with the results of investigation will be sent.

Manufacturer Narrative

Section h3, h6: the cori drill long attachment, p/n rob10015, sn (b)(6), intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported event was visually and functionally confirmed.The long attachment was out of specifications.The torque was found to be on 8 oz.In, instead of 20 oz.Lb as design.Even when the reported issue was confirmed visually, a functional evaluation was performed.The long attachment got stuck in the drill.Once the torque was adjust, it operated as design.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is normal wear.Vibrations can caused the long attachment torque came out of specifications.A historical capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12827979
• MDR Text Key: 282973929
• Report Number: 3010266064-2021-00769
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ROB20000, CORI ROBOTICS USA, SN (B)(6)